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General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas (GAMMA)

Primary Purpose

Gliomas Benign, Glioma, Malignant, Metastases to Brain

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Tumor resection in awake patient
Tumor resection in asleep patient
Sponsored by
Sklifosovsky Institute of Emergency Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gliomas Benign focused on measuring contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • single gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas)
  • single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
  • one or several brain metastases from any cancer
  • location in motor areas
  • newly diagnosed
  • Karnofsky Performance Status 60-100%
  • age 18-69 years
  • body mass index 29 and less
  • hemoglobin 110 and more
  • platelets 100 and more
  • international normalized ratio less than 2,0
  • presumed blood loss no more than 8-10 percents of circulating blood volume (no more than 450-650 milliliters)

Exclusion Criteria:

  • chronic obstructive pulmonary disease
  • persistent smoker (smoking index 11 and more)
  • major comorbidities
  • implanted pacemaker
  • inability to perform intraoperative tests before surgery
  • severe aphasia
  • psychiatric disorders
  • barely controlled seizures
  • contraindications to magnetic resonance imaging
  • previously performed brain radiotherapy
  • pregnancy
  • breast feeding

Sites / Locations

  • Sklifosovsky Institute of Emergency CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Awake surgery

General anesthesia

Arm Description

Critical steps of brain mapping and tumor removal will be performed in awake patient

Brain mapping and tumor removal will be performed in asleep patient

Outcomes

Primary Outcome Measures

Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
Motor function is assessed in Medical Research Council scale and is compared before and after surgery, deterioration of motor function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe disturbance means decline to 9 points or less
Dynamics of early motor function (in grades)
Early motor function is assessed in Medical Research Council scale and is compared before and after surgery
Dynamics of late motor function (in grades)
Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery

Secondary Outcome Measures

Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause
Speech function is assessed in Hendrix scale (2017) and is compared before and after surgery, deterioration of speech function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe depressing means decline to 9 points or less
Early speech function (in grades)
Early speech function is assessed in Hendrix scale (2017)
Early Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Gross total resection (Yes or No)
Absence of tumor tissue in postoperative magnetic resonance imaging
Duration of surgery (in minutes)
Duration of surgery from skin incision till last skin suture
Intraoperative blood loss (in milliliters)
Blood loss from skin incision till last skin suture
Duration of stay in intensive care unit (in days)
How long patient was treated in intensive care unit
Duration of hospital stay (in days)
How long patient was treated in the hospital from admission till discharge
Cerebral complications
Which cerebral complications arose after surgery
Somatic complications
Which somatic disorders arose after surgery
Repeated hospital admission (Yes or No)
Whether repeated hospital admissions were required due to postoperative complications
Late speech function (in grades)
Late speech function is assessed in Hendrix scale (2017)
Late Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

Full Information

First Posted
July 25, 2022
Last Updated
December 12, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
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1. Study Identification

Unique Protocol Identification Number
NCT05485038
Brief Title
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas
Acronym
GAMMA
Official Title
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.
Detailed Description
Awake surgery is usually used for tumor resection located in language areas. But patient's awakening during removal of mass lesions from motor areas can give additional opportunities. Besides checking of muscle contractions and integrity of motor fibers a surgeon in awake patient can assess planning of movements, praxis, visual feedback and vestibular processing of motions. Preserving of voluntary movements can be an additional proof that cortical motor centers and corticospinal tract were not damaged. At the moment there are no published results of randomized trials showing advantage of awake surgery in removal of mass lesions from motor brain areas. Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia. Participants of the study will be randomly operated using awake surgery or general anesthesia. In both groups intraoperative neuromonitoring will be used. Dynamics of motor functions will be assessed before and after surgery by blinded neurologists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gliomas Benign, Glioma, Malignant, Metastases to Brain
Keywords
contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Dynamics of motor function before, within 10 days after surgery and in 3 months after surgery will be assessed by neurosurgeon blinded for the treatment arm
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Awake surgery
Arm Type
Experimental
Arm Description
Critical steps of brain mapping and tumor removal will be performed in awake patient
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Brain mapping and tumor removal will be performed in asleep patient
Intervention Type
Procedure
Intervention Name(s)
Tumor resection in awake patient
Intervention Description
Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements
Intervention Type
Procedure
Intervention Name(s)
Tumor resection in asleep patient
Intervention Description
Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping
Primary Outcome Measure Information:
Title
Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
Description
Motor function is assessed in Medical Research Council scale and is compared before and after surgery, deterioration of motor function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe disturbance means decline to 9 points or less
Time Frame
within 10 days after surgery
Title
Dynamics of early motor function (in grades)
Description
Early motor function is assessed in Medical Research Council scale and is compared before and after surgery
Time Frame
within 10 days after surgery
Title
Dynamics of late motor function (in grades)
Description
Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery
Time Frame
in 3 months after surgery
Secondary Outcome Measure Information:
Title
Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause
Description
Speech function is assessed in Hendrix scale (2017) and is compared before and after surgery, deterioration of speech function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe depressing means decline to 9 points or less
Time Frame
within 10 days after surgery
Title
Early speech function (in grades)
Description
Early speech function is assessed in Hendrix scale (2017)
Time Frame
within 10 days after surgery
Title
Early Karnofsky performance status (in percents)
Description
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Time Frame
within 10 days after surgery
Title
Extent of resection (in percents)
Description
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time Frame
within 48 hours after surgery
Title
Gross total resection (Yes or No)
Description
Absence of tumor tissue in postoperative magnetic resonance imaging
Time Frame
within 48 hours after surgery
Title
Duration of surgery (in minutes)
Description
Duration of surgery from skin incision till last skin suture
Time Frame
Intraoperatively
Title
Intraoperative blood loss (in milliliters)
Description
Blood loss from skin incision till last skin suture
Time Frame
Intraoperatively
Title
Duration of stay in intensive care unit (in days)
Description
How long patient was treated in intensive care unit
Time Frame
From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days
Title
Duration of hospital stay (in days)
Description
How long patient was treated in the hospital from admission till discharge
Time Frame
From admission to the hospital till hospital discharge, up to 365 days
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
within 3 months after surgery
Title
Somatic complications
Description
Which somatic disorders arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Title
Repeated hospital admission (Yes or No)
Description
Whether repeated hospital admissions were required due to postoperative complications
Time Frame
within 3 months after surgery
Title
Late speech function (in grades)
Description
Late speech function is assessed in Hendrix scale (2017)
Time Frame
in 3 months after surgery
Title
Late Karnofsky performance status (in percents)
Description
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Time Frame
in 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas) single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) one or several brain metastases from any cancer location near primary motor area or corticospinal tract newly diagnosed Karnofsky Performance Status 60-100% muscle strength in assessed limbs 3-5 points in Medical Research Council scale age 18-69 years body mass index 29 and less hemoglobin 110 and more platelets 100 and more international normalized ratio less than 2,0 presumed blood loss no more than 8-10 percents of circulating blood volume (no more than 450-650 milliliters) Exclusion Criteria: chronic obstructive pulmonary disease persistent smoker (smoking index 11 and more) major comorbidities implanted pacemaker inability to perform intraoperative tests before surgery severe aphasia psychiatric disorders barely controlled seizures contraindications to magnetic resonance imaging previously performed brain radiotherapy pregnancy breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru

12. IPD Sharing Statement

Plan to Share IPD
No

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General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas

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